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Panels › Neurology › Product code GWJ · Class 2

Stimulator, Auditory, Evoked Response

Regulation 882.1900

0510(k)s in 12 months (76 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
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Top companies in GWJ

Company510(k)sRecalls
Intelligent Hearing Systems81
Bio-Logic Systems Corp.70
Natus Medical Incorporated51
Gn Otometrics31
Path Medical GmbH40
Amplaid USA, Inc.30
Interacoustics A/S30
Micro-Shev , Ltd.30
Teca, Inc.30
Vivosonic, Inc.30
Decided510(k)Device and applicantCode
Dec 19, 2024K242954Integrity V500 (Integrity, Integrity with VEMP)
Vivosonic, Inc., CA
GWJ
Mar 8, 2024K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA
GWJ
Aug 3, 2022K220139QScreen
Path Medical GmbH, DE
GWJ
Oct 14, 2021K211147ALGO 7i
Path Medical GmbH, DE
GWJ
Apr 24, 2020K193033GSI Audera Pro
Grason Stadler
GWJ
Sep 29, 2017K163326SmartEP
Intelligent Hearing Systems
GWJ
Mar 23, 2017K162037Eclipse with VEMP
Interacoustics A/S, DK
GWJ
Oct 23, 2015K143670ICS CHARTR EP 200 WITH VEMP
Gn Otometrics A/S, DK
GWJ
Aug 22, 2014K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
Natus Medical Incorporated
GWJ
Feb 27, 2014K132957MADSEN ACCUSCREEN TYPE 1077
Gn Otometrics
GWJ
Jun 27, 2013K131141EARPROBE
Path Medical GmbH, DE
GWJ
Apr 5, 2013K123701HEARLAB ACA
Frye Electronics, Inc.
GWJ
Sep 27, 2012K122067TYPE 1077 ACCUSCREEN
Gn Otometrics, DK
GWJ
Jul 25, 2011K111555CIRCUMAURAL ADHESIVE REPLACEMENT
R & D Medical Products, Inc.
GWJ
May 5, 2011K103760TITAN
Interacoustics A/S, DK
GWJ
Jul 1, 2010K100661EARPROBE
Path Medical GmbH
GWJ
Sep 3, 2009K092373ICS CHARTR EP 200
Gn Otometrics
GWJ
Jul 7, 2009K090579SMARTSCREENER-PLUS2
Intelligent Hearing Systems
GWJ
Feb 20, 2009K083399ICS CHARTR EP 200
Gn Otometrics A/S
GWJ
Jan 29, 2009K082035MAICO MB 11 WITH BERAPHONE PROBE
Maico Diagnostics
GWJ
Apr 4, 2008K080060VIVOSONIC NEUROSCREEN
Vivosonic, Inc., CA
GWJ
Feb 28, 2008K073384SMART COUPLER, MODEL M015401
Intelligent Hearing Systems
GWJ
Feb 5, 2008K073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
Bio-Logic Systems Corp.
GWJ
Jan 25, 2008K073665ALGO 5 NEWBORN HEARING SCREENER
Natus Medical, Inc.
GWJ
Jul 18, 2007K070608SMARTEP, MODEL M010000
Intelligent Hearing Systems
GWJ
Jun 29, 2007K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
Interacoustics A/S
GWJ
Jun 23, 2006K061443SMART USBLITE, MODEL M011120
Intelligent Hearing Systems
GWJ
Jan 24, 2005K043396INTEGRITY, MODEL V500
Vivosonic, Inc., CA
GWJ
Feb 20, 2004K031051SMARTEP-ASSR, MODEL M811007
Intelligent Hearing Systems
GWJ
May 9, 2003K030907STACKED ABR FOR NAVIGATOR PRO
Bio-Logic Systems Corp.
GWJ
Apr 28, 2003K031009MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
Bio-Logic Systems Corp.
GWJ
Apr 9, 2003K030823ALGO 3I NEWBORN HEARING SCREENER
Natus Medical, Inc.
GWJ
Jul 1, 2002K021895BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
Bio-Logic Systems Corp.
GWJ
Jun 14, 2002K013977ECHO-SCREEN T, TA, TD, TDA, TC
Fischer-Zoth Audiologic Systems, Inc.
GWJ
May 15, 2002K021215BIO-LOGIC ABAER CUB
Bio-Logic Systems Corp.
GWJ
Jan 8, 2002K011842SABRE COMPAC
Sle Limited
GWJ
Dec 18, 2001K012415AURIS AEP
Synapsys, Inc.
GWJ
Oct 16, 2001K013137ALGO 3 NEWBORN HEARING SCREENER
Natus Medical, Inc.
GWJ
Aug 24, 2001K011746MB 11
Maico Diagnostic GmbH
GWJ
Dec 13, 2000K002985ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
Ics Medical Corp.
GWJ
Dec 27, 1999K994149MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
Bio-Logic Systems Corp.
GWJ
Nov 16, 1999K993177SABRE
Sle Limited
GWJ
Oct 25, 1999K991853INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
Idem (Int'L Dist. of Electronics For Medicine)
GWJ
Sep 14, 1999K992807BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
Bio-Logic Systems Corp.
GWJ
Jan 30, 1998K972157EXCEL AV STIM 1000
Excel Tech. , Ltd., CA
GWJ
Feb 21, 1997K960097CHARTR EP
Ics Medical Corp.
GWJ
Oct 19, 1995K953732TECA PREMIERE
Medelec , Ltd., DE
GWJ
Sep 19, 1995K952080CLARITY SYSTEM II
Sonamed Corp.
GWJ
Jan 5, 1995K936039ALGO-2 NEWBORN HEARING SCREENER
Natus Medical, Inc.
GWJ
May 11, 1993K925648SMART-SCREENER (AUDITORY)
Intelligent Hearing Systems
GWJ

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